A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients With Acute Ischemic Stroke (NCT06700824) | Clinical Trial Compass
CompletedPhase 2
A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients With Acute Ischemic Stroke
France60 participantsStarted 2025-03-14
Plain-language summary
The MaTRISS 2 study is a phase 2 randomized, double-blinded and placebo-controlled trial aimed at recruiting 60 subjects (30 placebo and 30 active) from 15 stroke centers in France. The main objective will be to assess the efficacy of OTR4132-MD in patients with anterior ischemic stroke after endovascular thrombectomy. One dose will be tested (2 mg) against placebo. The main outcomes will be NIHSS (neurological score) at 24 hours, rate of intracranial hemorrhages at 24 hours, MRI lesion volume at 3 months and neurological scores at 3 months.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 18 and 85 years
. Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI).
. Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
. Endovascular thrombectomy (with or without previous intravenous thrombolysis)
. Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
. NIHSS (National Institute of Health Stroke Scale/Score) ≥ 11
. Pre-stroke modified Rankin Score (mRS): 0 or 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline-Adjusted 24-Hour NIHSS
Timeframe: 24 hours
Trial details
NCT IDNCT06700824
SponsorOrgan, Tissue, Regeneration, Repair and Replacement
. Patient\* or legally authorized representative (family member or trusted person if patient unable to give consent) or independent physician (if patient unable to give consent and if an authorized representative cannot be reached) has signed informed consent.
Exclusion criteria
. Previous symptomatic stroke with permanent sequelae
. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation
. Contraindication to MRI
. Stroke lesion not visible on MRI
. History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
. History of hypersensitivity or anaphylactic reactions to iodinated contrast media